DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 29 June 2026 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 136, 140-143, 145-151, 155, 157-159 and 162-166 are rejected under 35 U.S.C. 103 as being unpatentable over Nowak USPGPub 20200061022.
Regarding claims 136, 145-148 and 162-166, Nowak teaches a powder composition [0018] comprising
one or more isolated cannabinoids [0019]
a lipid composition consisting of one or more triglyceride solubilizing agents such as hydrogenated vegetable oil [0020,0025,0062]
optional silicon dioxide [0048] (a filler and or texturizer)
intra-granular excipient selected from, inter alia, diluents such as sucrose, isomalt, mannitol and sorbitol or binders such as sugars, all of which are sweeteners [0046-0047]
Nowak is silent regarding the precise proportions or ratios of components recited in claims 36, 145, 147, 148 and 162-166, however, the disclosure of the presence of these ingredients encompasses proportions that range from 0% to 100% less the proportion of other components. As such, the disclosure of Nowak encompasses embodiments having the proportions and ratios of components recited in claims 136, 145, 147, 148 and 162-166. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) Additionally, It would have been obvious to one of ordinary skill in the art at the time the application was filed to have balanced the proportions of ingredient in the powder of Nowak to ensure efficient granulation. Therefore, the limitations of claims 36, 145-148 and 162-166 are rendered obvious by Nowak.
Regarding claims 140 and 141, the oils of Nowak are blends of triglycerides that are liquid at or above 0 degrees C. [0062]
Regarding claims 142 and 143, although Nowak does not disclose the processing conditions recited in claims 142 and 143, it is noted that “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) . Further, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113.
Therefore, absent evidence of criticality regarding the presently claimed temperatures and order of combining ingredients and given that Nowak teaches a composition as claimed, the composition of Nowak clearly meets the requirements of present claims 142 and 143.
Regarding claims 149 and 150, Nowak teaches THC and CBD. [0019]
Regarding claim 151, it would have been obvious to one of ordinary skill in the art at the time the application was filed to have employed THC or CBD concentrates having the highest purity available in order to avoid adulterants.
Regarding claim 155, the composition of Nowak is ready to use.
Regarding claims 157-159, Nowak teaches forming tablets from the composition disclosed. [0077] Nowak teaches that the powders disclosed can be blended with extra-granular excipients and processed into a dosage form. The disclosure of Nowak encompasses proportions of the powder as recited in claim 158. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)
Claims 137, 138 and 144 are rejected under 35 U.S.C. 103 as being unpatentable over Nowak USPGPub 20200061022 in further view of Marten “Medium-chain triglycerides”, Internatl. Dairy Jour. 16 (2006) 1374–1382.
Regarding claims 137, 138 and 144, Nowak teaches what has been recited above but is silent regarding the triglycerides recited in claims 137, 138 and 144.
Marten teaches “The term medium-chain triacylglycerols refers to mixed triacylglycerols of saturated fatty acids with a chain length of 6–10 carbons, i.e., hexanoic acid (C6:0, common name capronic acid), octanoic acid (C8:0, common name caprylic acid), and decanoic acid (C10:0, common name capric acid). Sometimes, dodecanoic acid (C12:0, common name lauric acid) is included.” (Sec. 1) MCTs produced from coconut oil contain almost exclusively octanoic and decanoic acid, at a ratio from 50:50 to 80:20. (Sec. 2) Marten states “In a number of studies, but not always, beneficial effects of MCTs on weight control and glucose as well as on lipid metabolism were observed. This may prove the usefulness of natural foods containing relatively high amounts of MCFAs as well as the usefulness of functional foods supplemented with MCTs.” (Sec. 8)
Nowak and Marten are both directed to compositions comprising coconut oil. It would have been obvious to one of ordinary skill in the art at the time the application was filed to have substituted MCT oil derived from coconut oil as the solubilizing agent in Nowak since coconut oil was identified by Nowak as a suitable solubilizing agent and Marten teaches that MCTs are useful ingredients in food for their health benefits. This obvious modification of Nowak with Marten renders obvious the limitations of claims 137, 138 and 144.
Response to Arguments
Applicant's arguments filed 29 June 2026 have been fully considered but they are not persuasive.
Applicant asserts on page 8 of the remarks that the present claim amendments exclude non-triglyceride constituents from the lipid composition itself. While this may be true, the claim has been amended to also recite that the overall composition comprises the stated components and therefore the claimed premixture as a whole does not exclude the presence of any of the additional non-triglyceride solubilizing agents disclosed by Nowak. The claim merely recites “a lipid” and does not preclude the presence of other lipids in addition to the lipid recited because of the open nature of the claim. Furthermore, Nowak clearly encompasses embodiments where the solubilizing agents are only triglyceride. As such, applicant’s assertion is not found persuasive.
Applicant asserts on page 8 of the remarks that the present claim amendments exclude non-sweetener excipients from the claims. Just as with applicant’s assertions regarding the claimed lipid, the presently open-ended claims do not exclude the presence of additional materials. Furthermore, Nowak clearly encompasses embodiments where the excipient is only sweeteners. As such, applicant’s assertion that the rejection is based on hindsight is not found persuasive.
Applicant asserts on pages 8-9 of the remarks that because Nowak teaches an example outside the scope of the claims, the remainder of Nowak is not relevant. However, as stated in MPEP 2123 II. "Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). “A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994)
Applicant asserts on page 9 of the remarks that the interpretation of Nowak as disclosing all ratios of the components in the mixtures disclosed is unreasonable because silence cannot be treated as disclosure. The rejection does not treat silence as disclosure. Instead, the Nowak reference has been interpreted for all that it would reasonably convey to one of ordinary skill in the art, namely, that in the face of no explicit guidance in Nowak, one of ordinary skill would interpret the mixtures disclosed to encompass all embodiments of proportions of the ingredients. Applicant has failed to demonstrate the criticality of the proportions of any of the components claimed and therefore the present claims merely reflect an embodiment encompassed by Nowak that has not been shown to provide any function not provided by the mixtures of Nowak.
Applicant asserts on page 9 of the remarks that the reliance on the motivation of efficient granulation is improper because this motivation does not explicitly address the cannabinoid loading, limited lipid and sweetener compositions or the triglyceride to sweetener ratio claimed. However, as would be apparent to one of ordinary skill in the art, the amount of all of the ingredients would affect granulation requiring one of ordinary skill to balance cannabinoid delivery with granule formation. As explained above, the instant claims do not actually exclude other compositions from the claim. Again, applicant has failed to demonstrate any criticality to the recited proportions and therefore the claims merely reflect an embodiment encompassed by Nowak that has not been shown to provide any function not provided by the mixtures of Nowak.
Applicant asserts on page 10 of the remarks that the specification explains why the amended formulation is not simply an arbitrary selection, but fails to identify any teaching or evidence demonstrating the criticality of the proportions listed. As such, this assertion is not found persuasive.
Applicant asserts on page 10 of the remarks that despite Nowak disclosing that the components making up the composition are suitable for oral formulations, that combinations of the components disclosed by Nowak as useful together are not reasonably disclosed. This is not logical. Applicant’s further assertions regarding “particular selection and organization” are not persuasive since as discussed above, the new limitations do not result in a closed composition.
Applicant asserts on page 11 of the remarks that the declaration of Dr. Neergaard provides claim interpretation of the instantly pending claims. It is not clear how Dr. Neergaard’s opinion of the interpretation of the instantly pending claims is relevant as Dr. Neergaard has not been demonstrated to be a patent practitioner. The broadest reasonable interpretation of the instantly pending claims does not exclude agglomerates because agglomerated particles still form powders. As such, these assertions are not persuasive.
Applicant asserts on page 11 of the remarks and in paragraph 6 of the declaration that the examples of Nowak do not read on the present claims. This assertion is not found persuasive since as discussed above, disclosures are not limited to the examples and applicant has taken an improperly narrow view of the interpretation of the present claims.
Applicant asserts on page 12 of the remarks and Dr. Neergaard asserts in paragraphs 7 and 8 of the declaration that the present invention has no similarity to Nowak and that the sweetener in Nowak is present in agglomerated particles and is therefore not a sweetener powder as claimed. The present claims do not require that the sweetener powder is not agglomerated. Only that it is a powder composition. When a powder is mixed with other components, the overall composition still comprises the powder. There is no positive recitation in the claims that the sweetener powder cannot be agglomerated. Dr. Neergaard asserts in paragraph 7 of the declaration that mixing lipid with two powder compositions and heating resulted in a composition where the maltitol was maintained as individual particles. However, no evidence has been provided to demonstrate the mixture was analyzed to determine that despite being mixed with lipid, no agglomeration occurred. Additionally, the present claims only recite one powder composition. Applicant’s interpretation of the “sweetener powder” presently claimed would render the instantly pending claims indefinite since despite being mixed with lipid and cannabinoids, applicant asserts that the sweetener powder is excluded from being in contact with either cannabinoid or lipid. If sweetener powder is the only powder present, the overall composition cannot be a powder if the cannabinoid and lipid are excluded from contacting the powder.
Applicant asserts on pages 12-13 of the remarks and paragraph 9 of the declaration that one of ordinary skill in the art would not have a reasonable expectation of success to “come to the instantly claimed invention”, but fails to provide any reasoning to support this conclusory assertion. Applicant asserts on pages 12-13 and paragraph 9 of the declaration that one of ordinary skill in the art would not consult Brunn, however, the Brunn reference was not relied on in the previously pending rejection so it is unclear how these remarks are germane. As such, applicant’s assertions are not found persuasive.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michele L Jacobson whose telephone number is (571)272-8905. The examiner can normally be reached Monday through Friday from 10-6.
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/Michele L Jacobson/Primary Examiner, Art Unit 1793
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